Abuse potential of mirogabalin in recreational polydrug users

Abstract

Mirogabalin is a selective calcium channel α₂δ subunit ligand being developed to treat neuropathic pain. In accordance with US Food and Drug Administration (FDA) guidance, the human abuse potential of mirogabalin (15-105 mg) was examined, relative to placebo, diazepam (15 or 30 mg), and pregabalin (200 or 450 mg), in two single-dose, randomized, double-blind, placebo- and active-controlled crossover studies in recreational polydrug users who could discern between positive comparator and placebo. The primary endpoint was maximum observed effect (<i>E</i> _max) for Drug Liking Visual Analog Scale. At therapeutic doses, mirogabalin Drug Liking <i>E</i> _max did not differ significantly from placebo and was significantly lower than diazepam and pregabalin. This indicates therapeutic doses mirogabalin may have less abuse potential <i>versus</i> diazepam or pregabalin. At supratherapeutic doses (⩾4× therapeutic dose), mirogabalin had significantly higher Drug Liking <i>E</i> _max than placebo, but lower <i>E</i> _max than pregabalin. In both studies, therapeutic doses of mirogabalin demonstrated limited evidence of abuse potential.